Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Foley Hoag LLP
The Eleventh Circuit agreed with the trial court that the government must do more than present expert evidence that a physician's clinical judgment was inaccurate to establish falsity
Eide Bailly LLP
The new lease standard from the Financial Accounting Standards Board (FASB) was released in February 2016. With it came sweeping changes
Miller Starr Regalia
On August 19, 2019, the California Supreme Court issued its unanimous 38-page opinion, authored by Chief Justice Cantil-Sakauye, in the CEQA "project definition" case we've been tracking with interest.
Sheppard Mullin Richter & Hampton
In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court's holding
Foley & Lardner
Tuesday's ruling by the United States Court of Appeals for the Eleventh Circuit in United States v. AseraCare is a win for hospice and other health care providers who have long argued
Hogan Lovells
More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that "contradiction based on clinical
Mintz
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc..
Jones Day
The proposed rules apply to all hospitals, regardless of whether they receive federal funding.
Sheppard Mullin Richter & Hampton
On September 5, 2019, the Centers for Medicare and Medicaid Services ("CMS") released a final rule with comment period entitled, "Program Integrity Enhancements to the Provider Enrollment Process"
BakerHostetler
FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food products
Hogan Lovells
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
Thompson Coburn LLP
A few days before the Fourth of July, a new law went into effect in Mississippi making it a misdemeanor
Reed Smith
We had been waiting for the Utah Supreme Court's decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court
Foley Hoag LLP
Today, in the first settlement of its kind, the Office for Civil Rights at the U.S. Department of Health and Human Services ("OCR") announced that Bayfront
Hogan Lovells
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests.
Reed Smith
Just as the U.S. Food & Drug Administration ("FDA") promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register
Foley & Lardner
These days, almost all employer-sponsored group health plans require an employee (and any dependents) covered under the plan
BakerHostetler
Congress reconvenes this week after a monthlong summer recess and begins what likely will be a final push toward overhauling
Cooley LLP
An applicant whose enrollment has been revoked twice will not be permitted to reenroll for up to 20 years.
Dentons
US attorneys and public officials convene at a closed-door "Marijuana Summit" in Oregon
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Jones Day
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Jones Day
On the heels of the European Union's General Data Protection law, which went into effect in May 2018
Dentons
Cannabis sales expand throughout the South, with Arkansas dispensaries offering delivery services and Louisiana dispensaries making their first medical cannabis sales; New
Butler Snow LLP
Many state legislatures across the country have enacted statutory measures to limit the amount of compensatory and/or punitive damages recoverable ...
Oblon, McClelland, Maier & Neustadt, L.L.P
Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined
Holland & Knight
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2018, published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS).
Dentons
The National Credit Union Administration affirms that credit unions may provide financial services to hemp businesses.
McDermott Will & Emery
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning
Gibson, Dunn & Crutcher
Halfway through 2019 and the third year of the Trump Administration, we continue to observe complex trends in the health care regulatory and enforcement environment impacting providers.
Reed Smith
What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support. Part One was last week.
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